MAUDE Adverse Event Report: COOK INC C-FLEX DOUBLE PIGTAIL URETERAL STENT SET; FAD STENT, URETERAL

Model Number G14834

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2021

Event Type  malfunction  

Event Description

As reported, during a laparoscopic pyeloplasty, the coating of a wire guide of a c-flex double pigtail ureteral stent set separated from the wire.The wire was activated using water and handled using latex gloves.The wire and stent were placed in the ureter without complication.As the wire guide was removed, the coating peeled from the device, and the stent lost its shape.The stent was withdrawn from the patient.A photo of the stent appears to show the distal tip damaged.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Additional event information has been requested.

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: b5 corrected information: h6: component code (annex g) description of event: as reported, during a laparoscopic pyeloplasty, the coating of a wire guide of a c-flex double pigtail ureteral stent set separated from the wire.The wire was activated using water and handled using latex gloves.The wire and stent were placed in the ureter without complication.As the wire guide was removed resistance was noted, the coating peeled from the device, and the stent lost its shape.The stent was withdrawn from the patient.The procedure was completed by replacing the stent with another same type device.Investigation ¿ evaluation a document based investigation was performed including a review of complaint history, device history record, the instructions for use, manufacturing instructions, and quality control data.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was made out of specification.Photos were provided which show material from the wire guide has separated and the wire guide has become unravelled.A photo of one end of the stent shows it to be torn and deformed on one end.The positioner is shown with a hole located one third of the way down its length of the positioner that is less than the diameter of positioner tubing.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precaution -manipulation of the wire guide requires appropriate imaging control.Use caution not to force or over manipulate the wire guide when gaining access.-when using a wire guide through a metal cannula/needle, use caution as damage may occur to the outer coating.-do not force components during removal or replacement.If resistance is encountered, stop.Determine the cause of the resistance before proceeding.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Damage was observed on all 3 components in the photos; the wireguide had separated and unraveled, the stent was torn and deformed at one end and the positioner has a small hole approximately one third of the way down its length.Cook has concluded this complaint was not contributed to by a manufacturing defect.Cook has concluded a specific cause for the complaint could not be established.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information received on 25jan2022: the guidewire was advanced without issue, however resistance was noted when removing the device.The wire was only used to advance the stent.The procedure was completed by replacing the stent with another stent.

• Brand Name: C-FLEX DOUBLE PIGTAIL URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 13152901
• MDR Text Key: 290160197
• Report Number: 1820334-2022-00010
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002148345
• UDI-Public: (01)00827002148345(17)231216(10)13634270
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162104
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2023
• Device Model Number: G14834
• Device Catalogue Number: 036312
• Device Lot Number: 13634270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 01/04/2022
• Supplement Dates Manufacturer Received: 01/25/2022
• Supplement Dates FDA Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female